NCT02500797 · STUDY IN CONTEXT

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The number of participants who achieved a confirmed response is defined as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks as determined using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites).

Participants who completed the study and were evaluable for the primary endpoint are included in this analysis.

→

secondary · POSTED

The number of participants who experienced at least one grade 3 or higher adverse event (AE) regardless of attribution. AEs are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018).

Randomized patients who received treatment (i.e. exclude cancel patients).

→

secondary · POSTED

Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).

Participants who achieved a confirmed response are included in this analysis.

→

secondary · POSTED

The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).

Randomized Initial Cohort participants who received treatment (i.e. exclude cancel patients) Only.

→

secondary · POSTED

The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).

Randomized Expansion LPS and UPS/MFH Cohorts Participants who received treatment Only

→

secondary · POSTED

The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).

Randomized Expansion GIST Cohort Participants who received treatment Only.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-bone-sarcoma
nct id: NCT02500797
trial label: Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
source section id
NCT02500797-om-0000
source outcome index
0
endpoint
Number of Participants Who Achieved a Confirmed Response
endpoint definition
The number of participants who achieved a confirmed response is defined as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks as determined using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites).
time origin
Up to 44 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who completed the study and were evaluable for the primary endpoint are included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0001
source section id
NCT02500797-om-0001
source outcome index
1
endpoint
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution
endpoint definition
The number of participants who experienced at least one grade 3 or higher adverse event (AE) regardless of attribution. AEs are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018).
time origin
Up to 4 weeks after completion of study treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Randomized patients who received treatment (i.e. exclude cancel patients).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0002
source section id
NCT02500797-om-0002
source outcome index
2
endpoint
Duration of Response
endpoint definition
Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).
time origin
Time from first response to progression, assessed up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who achieved a confirmed response are included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0003
source section id
NCT02500797-om-0003
source outcome index
3
endpoint
6-Month Clinical Benefit Rate [Initial Cohort]
endpoint definition
The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
time origin
At 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Randomized Initial Cohort participants who received treatment (i.e. exclude cancel patients) Only.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0004
source section id
NCT02500797-om-0004
source outcome index
4
endpoint
6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only]
endpoint definition
The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
time origin
At 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Randomized Expansion LPS and UPS/MFH Cohorts Participants who received treatment Only
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0005
source section id
NCT02500797-om-0005
source outcome index
5
endpoint
6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]
endpoint definition
The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
time origin
At 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Randomized Expansion GIST Cohort Participants who received treatment Only.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG000
arm label
Initial Single
regimen
Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG001
arm label
Initial Dual
regimen
Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG002
arm label
LPS Single
regimen
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG003
arm label
LPS Dual
regimen
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG004
arm label
UPS/MFH Single
regimen
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG005
arm label
UPS/MFH Dual
regimen
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG006
arm label
GIST Single
regimen
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0000
arm key
OG007
arm label
GIST Dual
regimen
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0001
arm key
OG000
arm label
Initial Single
regimen
Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress on single agent nivolumab may elect to cross over to Initial Cohort - Arm II.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0001
arm key
OG001
arm label
Initial Dual
regimen
Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0001
arm key
OG002
arm label
LPS Single
regimen
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
outcome key
om-0001
arm key
OG003
arm label
LPS Dual
regimen
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02500797-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG000
source section id
NCT02500797-ae
event group key
EG000
event group label
Initial Single
serious affected
19
serious at risk
42
other affected
39
other at risk
42
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG001
source section id
NCT02500797-ae
event group key
EG001
event group label
Initial Dual
serious affected
21
serious at risk
42
other affected
40
other at risk
42
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG002
source section id
NCT02500797-ae
event group key
EG002
event group label
LPS Single
serious affected
9
serious at risk
15
other affected
15
other at risk
15
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG003
source section id
NCT02500797-ae
event group key
EG003
event group label
LPS Dual
serious affected
1
serious at risk
14
other affected
14
other at risk
14
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG004
source section id
NCT02500797-ae
event group key
EG004
event group label
UPS/MFH Single
serious affected
8
serious at risk
13
other affected
12
other at risk
13
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG005
source section id
NCT02500797-ae
event group key
EG005
event group label
UPS/MFH Dual
serious affected
7
serious at risk
14
other affected
14
other at risk
14
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG006
source section id
NCT02500797-ae
event group key
EG006
event group label
GIST Single
serious affected
5
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02500797
harm key
EG007
source section id
NCT02500797-ae
event group key
EG007
event group label
GIST Dual
serious affected
6
serious at risk
11
other affected
10
other at risk
11
frequency threshold
0
collection period
Up to 4 weeks after completion of study treatment; up to 44 months
event definition
Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice